EP3836921C0 - LIQUID BENDAMUSTIN DRUG COMPOSITIONS - Google Patents

LIQUID BENDAMUSTIN DRUG COMPOSITIONS

Info

Publication number: EP3836921C0
Authority: EP; European Patent Office
Prior art keywords: bendamustin; liquid; drug compositions; drug; compositions
Prior art date: 2018-08-17
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Active

Application number

EP19850670.1A

Other languages

German (de)

French (fr)

Other versions

EP3836921B1 (en

EP3836921A4 (en

EP3836921A1 (en

Inventor

Andrew Malcolm Knill

Noel Norris

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Hospira Australia Pty Ltd

Original Assignee

Hospira Australia Pty Ltd

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2018-08-17

Filing date

2019-08-14

Publication date

2025-10-08

2019-08-14 Application filed by Hospira Australia Pty Ltd filed Critical Hospira Australia Pty Ltd

2021-06-23 Publication of EP3836921A1 publication Critical patent/EP3836921A1/en

2022-04-20 Publication of EP3836921A4 publication Critical patent/EP3836921A4/en

2025-10-08 Application granted granted Critical

2025-10-08 Publication of EP3836921B1 publication Critical patent/EP3836921B1/en

2025-10-08 Publication of EP3836921C0 publication Critical patent/EP3836921C0/en

Status Active legal-status Critical Current

2039-08-14 Anticipated expiration legal-status Critical

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Engineering & Computer Science (AREA)
Dermatology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

EP19850670.1A 2018-08-17 2019-08-14 Liquid bendamustine pharmaceutical compositions Active EP3836921B1 (en)

Applications Claiming Priority (4)

Application Number	Priority Date	Filing Date	Title
US201862764975P	2018-08-17	2018-08-17
US201862723725P	2018-08-28	2018-08-28
US201962815376P	2019-03-08	2019-03-08
PCT/IB2019/056903 WO2020035806A1 (en)	2018-08-17	2019-08-14	Liquid bendamustine pharmaceutical compositions

Publications (4)

Publication Number	Publication Date
EP3836921A1 EP3836921A1 (en)	2021-06-23
EP3836921A4 EP3836921A4 (en)	2022-04-20
EP3836921B1 EP3836921B1 (en)	2025-10-08
EP3836921C0 true EP3836921C0 (en)	2025-10-08

Family

ID=69525233

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP19850670.1A Active EP3836921B1 (en)	2018-08-17	2019-08-14	Liquid bendamustine pharmaceutical compositions

Country Status (6)

Country	Link
US (1)	US12246007B2 (en)
EP (1)	EP3836921B1 (en)
JP (2)	JP2021534253A (en)
AU (1)	AU2019321089A1 (en)
CA (1)	CA3108321A1 (en)
WO (1)	WO2020035806A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
KR20210078505A (en)	2018-10-16	2021-06-28	유에스 나노 푸드 앤 드럭 인코포레이티드	Intratumoral Injection Formulation
US11730815B2 (en)	2018-11-26	2023-08-22	Good Health, Llc	Stable liquid pharmaceutical compositions comprising bendamustine
PH12022552732A1 (en) *	2020-04-13	2024-03-25	US Nano Food & Drug INC	Basic chemotherapeutic intratumour injection formulation
GB202118175D0 (en)	2021-12-15	2022-01-26	Arecor Ltd	Novel composition
US11707450B1 (en)	2022-03-03	2023-07-25	Slayback Pharma Llc	Stable pharmaceutical compositions of bendamustine

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US8436190B2 (en)	2005-01-14	2013-05-07	Cephalon, Inc.	Bendamustine pharmaceutical compositions
AR072777A1 (en)	2008-03-26	2010-09-22	Cephalon Inc	SOLID FORMS OF BENDAMUSTINE CHLORHYDRATE
EP2889029A1 (en)	2008-09-25	2015-07-01	Cephalon, Inc.	Liquid formulations of bendamustine
DK3158991T3 (en)	2010-01-28	2021-06-14	Eagle Pharmaceuticals Inc	BENDAMUSTIN FORMULATIONS
WO2013112762A1 (en)	2012-01-24	2013-08-01	Innopharma, Inc.	Bendamustine compositions and methods therefore
HUE064884T2 (en)	2012-03-20	2024-04-28	Eagle Pharmaceuticals Inc	Formulations of bendamustine
ES2943668T3 (en)	2012-03-20	2023-06-15	Eagle Pharmaceuticals Inc	Bendamustine liquid compositions for use in a method of treating conditions responsive to bendamustine in patients requiring reduced volumes for administration
US20160235717A1 (en) *	2013-10-11	2016-08-18	Luitpold Pharmaceuticals, Inc.	Bendamustine pharmaceutical compositions
WO2016005995A2 (en) *	2014-07-10	2016-01-14	Leiutis Pharmaceuticals Pvt. Ltd.	Glycol free stable liquid compositions of bendamustine
WO2016059590A1 (en) *	2014-10-16	2016-04-21	Piramal Enterprises Limited	Stable injectable composition of small molecule drugs and process for its preparation
US9603930B2 (en)	2014-12-04	2017-03-28	Navinta, Llc	Liquid bendamustine formulation
CN110772480B (en) *	2016-03-25	2022-05-17	南京百劲企业管理咨询有限公司	Bendamustine medicament composition and application thereof
WO2017175098A1 (en) *	2016-04-05	2017-10-12	Leiutis Pharmaceuticals Pvt Ltd	Stable liquid pharmaceutical formulations of bendamustine
US10905677B2 (en) *	2016-08-31	2021-02-02	Navinta, Llc	Bendamustine solution formulations

2019
- 2019-08-14 US US17/268,780 patent/US12246007B2/en active Active
- 2019-08-14 CA CA3108321A patent/CA3108321A1/en active Pending
- 2019-08-14 AU AU2019321089A patent/AU2019321089A1/en not_active Abandoned
- 2019-08-14 EP EP19850670.1A patent/EP3836921B1/en active Active
- 2019-08-14 WO PCT/IB2019/056903 patent/WO2020035806A1/en not_active Ceased
- 2019-08-14 JP JP2021532537A patent/JP2021534253A/en not_active Withdrawn
2024
- 2024-05-28 JP JP2024086001A patent/JP2024109878A/en not_active Withdrawn

Also Published As

Publication number	Publication date
EP3836921B1 (en)	2025-10-08
EP3836921A4 (en)	2022-04-20
CA3108321A1 (en)	2020-02-20
JP2024109878A (en)	2024-08-14
JP2021534253A (en)	2021-12-09
US20210275500A1 (en)	2021-09-09
WO2020035806A1 (en)	2020-02-20
EP3836921A1 (en)	2021-06-23
US12246007B2 (en)	2025-03-11
AU2019321089A1 (en)	2021-02-11

Publication	Publication Date	Title
DK3256138T3 (en)	2022-05-16	PHARMACEUTICAL COMPOSITIONS INCLUDING MELOXICAM
EP3621621C0 (en)	2024-12-25	PHARMACEUTICAL COMPOSITIONS CONTAINING MELOXICAM
DK3529248T3 (en)	2020-09-14	Pharmaceutical compositions
DK3236943T3 (en)	2023-04-11	COMPOSITIONS FOR ILEO-JEJUNAL DRUG ADMINISTRATION
DK3727453T3 (en)	2025-06-23	LIQUID COMPOSITION FOR ADMINISTRATION
EP3513809A4 (en)	2020-06-03	MEDICINAL COMPOSITION
DK3479819T5 (en)	2024-09-09	STABLE LIQUID PHARMACEUTICAL PREPARATION
DK3655038T3 (en)	2025-02-17	PHARMACEUTICAL COMPOSITION
EP3905900C0 (en)	2024-05-15	LIQUID NICOTINE FORMULATION
DK3532029T3 (en)	2021-06-07	Liquid pharmaceutical composition
BR112016026879A2 (en)	2017-08-15	LIQUID PHARMACEUTICAL COMPOSITION
LT3116491T (en)	2021-08-10	PHARMACEUTICAL COMPOSITIONS OF THERAPEUTICLY ACTIVE COMPOUNDS
DK3634377T3 (en)	2021-08-30	Pharmaceutical formulation
EP3836921C0 (en)	2025-10-08	LIQUID BENDAMUSTIN DRUG COMPOSITIONS
DK3821905T3 (en)	2022-11-14	PHARMACEUTICAL COMPOSITIONS CONTAINING INSULIN
DK3583943T3 (en)	2024-10-14	PHARMACEUTICAL COMPOSITION
EP3402470A4 (en)	2019-11-13	STABLE PHARMACEUTICAL COMPOSITION
MA49837A (en)	2020-06-17	PHARMACEUTICAL COMPOSITIONS
DK3728220T3 (en)	2022-02-07	Pharmaceutical compounds
DK3313370T3 (en)	2021-03-29	Ophthalmological pharmaceutical composition
SMT202400478T1 (en)	2025-01-14	PHARMACEUTICAL COMPOSITION
EP3646863A4 (en)	2021-03-24	PHARMACEUTICAL COMPOSITION
DK3601277T3 (en)	2024-01-15	PHARMACEUTICAL FORMULATION
EP3646865A4 (en)	2021-03-17	DRUG
EP3590513A4 (en)	2020-12-30	DRUG

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2022-04-20	RIC1	Information provided on ipc code assigned before grant	Ipc: A61P 35/00 20060101ALI20220314BHEP Ipc: A61K 9/08 20060101ALI20220314BHEP Ipc: A61K 31/4184 20060101AFI20220314BHEP
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